Last week six Republicans in the US House of Representatives sent a letter to the FDA and FCC that explains the importance of wireless health devices and medical apps, cautions against slow and inconsistent regulations, and asks for a progress report on how the two regulatory bodies are working together to co-regulate these technologies. The six House members that signed the letter were: Rep....
The Duofertility Reader
Late last year the US Food and Drug Administration (FDA) cleared Duofertility, a computerized basal body temperature thermometer developed by Cambridge Temperature Concepts, with a 510(K). Cambridge Temperature Concepts developed the device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception,...
The FDA cleared Abbott's i-STAT 1 Wireless point-of-care blood analyzer last week, marking the fourth wireless-enabled medical device to receive FDA clearance so far this year. Ascom, Monica Healthcare and Mobisante have each received a 510(k) clearance this year for a connected medical device. The FDA has cleared more than a dozen software apps for mobile devices over the years including one...
A week ago, MobiHealthNews shot down the myth that the U.S. Food and Drug Administration (FDA) plans to start regulating mobile medical apps. In reality, the FDA has been regulating mobile software for years.
Way back in 1997, Data Critical, a company bought by GE Healthcare in 2001, earned FDA 510(k) clearance for its RhythmStat XL software that wirelessly transmits ECG data from a heart monitor...
In an opinion piece published in the Wall Street Journal this week, US President Barack Obama wrote that the US Food and Drug Administration (FDA) is set for reform: "Tomorrow the FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster," President Obama wrote Tuesday.
The next day...
AliveCor's iPhone ECG is not an FDA-approved medical device
Dr. David Albert is one of wireless medicine's old guards. As he puts it: "I did what AirStrip is doing 15 years ago with the first Nokia smartphone. I also have a patent that is probably the seminal patent for handheld ECGs, but GE owns that now since they acquired my company. I'm an old pro in this business."
If you hadn't heard about...
When it comes to popular MobiHealthNews stories in 2010, medical-related news about tablet devices dominated. Apps-related news continues to be a popular topic of discussion, but tablet news overtook apps news overall in 2010.
Four of our Top 10 Mobile Health Stories of 2010 are focused on tablets, including Apple's iPad, the BlackBerry Playbook and Cisco's Cius. Two apps related stories also...
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.
The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental questions: (1) what mHealth hardware and software will FDA regulate and (2) if a product is regulated, to what degree? The Coalition...
Dr. Mohit Kaushal, director of Connected Health at the Federal Communications Commission, has joined the West Wireless Health Institute as its new Executive Vice President of Business Development and Chief Strategy Officer. Kaushal is tasked with identifying and pursuing opportunities that help the WWHI fulfill its mission to bring down healthcare costs. Kaushal's role also includes making...
The Washington Post published a feature today on aging in place technologies: "Imagine a 75-year-old receiving wireless medication reminders, straight to his beeping wristband. Or an 80-year-old with a new hip, linked by body sensors to a device embedded in her carpet that tracks her movement patterns in case her mobility worsens." The Washington Post
Telecoms.com has a worthwhile high-level...
